Multinational Haemapheresis Vigilance Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Aix Scientifics
Information provided by (Responsible Party):
DGTI - Haemapheresis Vigilance Working Party
ClinicalTrials.gov Identifier:
NCT01576237
First received: April 10, 2012
Last updated: April 11, 2012
Last verified: April 2012

April 10, 2012
April 11, 2012
February 2012
February 2017   (final data collection date for primary outcome measure)
Assessment of all non-trivial adverse events (AE) occurring during hemapheresis [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]
All non-trivial AEs will be recorded regardless of whether anticipated products have been collected or not
Same as current
Complete list of historical versions of study NCT01576237 on ClinicalTrials.gov Archive Site
Rate of products per apheresis [ Time Frame: hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses ] [ Designated as safety issue: No ]
amount of obtained products vs. anticipated products
Same as current
Not Provided
Not Provided
 
Multinational Haemapheresis Vigilance Study
Open Prospective Multi-national Long-term Study to Register Adverse Events Related to Hemaphereses by Means of an Internet-based Haemapheresis Vigilance Questionnaire

During a five years period the participating transfusion medicine establishments will report all their non-trivial adverse events (AE) occurring during preparative hemaphereses. Complications may be related to the blood donors, the blood products, the disposables or the apheresis devices. The study hypothesis regarding each participating center is that their procedure-related AE rate is not higher than the respective rate of all other centers in total.

In the scope of this study the participating transfusion medicine establishments obligate themselves to record all significant Adverse Events (AE) related to preparative hemaphereses of healthy donors. All complications (phlebotomy and circulation problems, citrate toxicity, donor compliance, and technical complications) shall be assessed with respect to plasma-, platelet-, leukocyte- (stem cells, granulocytes, monocytes), and red cell aphereses as well as multicomponent aphereses. Study data are recorded by means of an Internet-based hemapheresis vigilance system. Study results will be evaluated according to the advanced standards of the International Haemovigilance Network (IHN). The study contributes to the quality assurance of each single center as it enables the comparison to other transfusion medicine establishments.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

all blood donors having an Adverse Event during preparative cell aphereses

Blood Donation With Hemapheresis
Other: blood donation
blood donation with preparative hemapheresis
healthy apheresis donors
Intervention: Other: blood donation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50000
February 2017
February 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • blood donor standard criteria :
  • healthy donor of > 50 kg
  • hemoglobin 125 g/L or 7.8 mmol/L (female donors)
  • hemoglobin 135 g/L or 8.4 mmol/L (male donors)
  • hemoglobin > 140 g/L for 2 unit red cell apheresis
  • total proteins >= 60 g/L for plasmapheresis
  • platelet count >= 150 × 10e9/L for platelet apheresis
  • blood volume of > 5 L for 2 unit red cell apheresis
  • normal leukocyte count
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01576237
DGTI-AGHV_01
Yes
DGTI - Haemapheresis Vigilance Working Party
DGTI - Haemapheresis Vigilance Working Party
Aix Scientifics
Principal Investigator: Hans-Gert Heuft, PD. Dr. med. Hannover Medical School (MHH)
DGTI - Haemapheresis Vigilance Working Party
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP